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Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels

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Multicenter, Open-label Study to Evaluate the Safety and Efficacy (by Blinded Reading) of Contrast-Enhanced Magnetic Resonance Angiography (MRA) After a Single Intravenous Injection of 0.1 mmol/kg Gadobutrol in Subjects With Known or Suspected Vascular Disease of the Supra-aortic Vessels

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jul 2019

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At a glance

  • Drugs Gadobutrol (Primary)
  • Indications Carotid stenosis; Renal Artery Obstruction; Vascular disorders
  • Focus Diagnostic use; Registrational
  • Acronyms GEMSAV
  • Sponsors Bayer; Bayer HealthCare

    • Most Recent Events

    • 12 Jul 2019 This trial has been completed in United Kingdom, according to European Clinical Trials Database.
    • 06 May 2016 New trial record
    • 29 Apr 2016 Primary endpoint has been met. (Specificity for Exclusion of Clinically Significant Disease Using Gadobutrol-Enhanced MRA and Unenhanced MRA)

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